Omega-3 Fatty Acid Supplementation to Enhance Performance

Body Composition Clinical Trial

— FO n-3  

Official title:

Omega-3 Fatty Acid Supplementation to Enhance Performance in Collegiate Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05924139
• Other study ID #: 1994931
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: June 2, 2023

Study information

• Verified date: June 2023
• Source: Baylor University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this intervention study is to determine if omega-3 fatty acid supplementation as compared to placebo improves performance in track and field athletes. The main questions it aims to answer are:

1. Can performance be improved

2. Can strength be enhanced

3. Will positive body composition changes occur (lean vs fat mass)

4. Will feelings of muscle soreness be diminished Participants will take either omega-3 fatty acid supplements or placebo and continue with their sport specific training regimen.

Researchers will compare the supplement group to placebo group to determine if there are any significant differences.

Description:

This is a randomized, placebo-controlled trial to determine the efficacy of fish oil-derived omega-3 fatty acid supplementation. Up to sixty participants will be randomized to receive one of two conditions: 4.0 grams of FO n-3/day or placebo (coconut oil) for the 10-week protocol study period. Nordic Naturals (Ultimate Omega) will be used as the intervention at a dose of 6 capsules/day (3840 mg total FO/1950 mg EPA/1350 mg DHA). Although protocols have varied among studies with regards to dosage, the proposed regimen was selected based on studies on strength in older adults and college-aged athletes utilizing a range of 2-5g FO n-3 per day. Blinded randomization will be accomplished with a research associate providing every first (of two) participants the placebo, while the second will receive the supplemented condition until recruitment is complete. Participants will be provided their supplement in 2-week increments and instructed to consume with/near their evening meal. Used bottles will be returned after two weeks and participants will receive the next 2-week supply of supplement and the leftover pill count will determine compliance rate.

The target population is apparently healthy college athletes (male and female of all ethnicities) between the ages of 18-25 years at Baylor University. Participants must be able to read and understand English and sign their own consent form. Up to 60 subjects will be recruited via direct contact or team briefings with permission of the coaches.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

Apparently healthy college athletes (male and female of all ethnicities) between the ages of 18-25 years.

Exclusion Criteria: -Participants will be excluded if they are unable to physically train due to injury/illness or are pregnant, or have a known heart condition or pacemaker.

Related Conditions & MeSH terms

• Body Composition
• Muscle Soreness
• Myalgia
• Strength

Intervention

Dietary Supplement:
• Omega-3 fatty acid
6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA
• Placebo
4 capsules per day of coconut oil

Locations

Country	Name	City	State
United States	Baylor University	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength	lower body strength will be evaluated via a counter movement jump	change from baseline at 8 weeks
Primary	Power	handgrip strength will be used as a proxy for upper body strength via a dynamometer	change from baseline at 8 weeks
Secondary	Body composition	bioelectrical impedance analysis (BIA), a double-indirect body composition technique based on a 3-component model (fat mass, fat-free mass, and total body water), will be performed.	change from baseline at 8 weeks
Secondary	Muscle soreness	Subjects will be asked to rate their muscle soreness on a 10-point Likert scale	change from baseline, every 2 weeks and at 8 weeks
Secondary	Omega-3 index	The Omega-3 Index provides information on the participants baseline level of EPA/DHA level in the blood	change from baseline at 8 weeks